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Trials
A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

trialsTrialRecruiting

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

A phase 1/2 trial of BNT329 in advanced solid tumours, run by BioNTech SE, now recruiting.

Overview Connected2

Overview

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9 is a phase 1/2 interventional study registered as NCT07186842 by BioNTech SE, with 245 participants planned, started 2025-11-18 and due to reach its primary completion in 2030-05. Interventions recorded: BNT329 and CA19-9-targeting monoclonal antibody.

Setting

First-in-human, Open-label, Multi-site, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9

Phase

Phase 1/2

Sponsor

BioNTech SE

Registry

Started

2025-11-18

Enrolled

245 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

companies

Evidence strength20/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
245 enrolled+12
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-16 · Jude Gomila · Registry trials wave 6 and products wave 7 · diff · file

Sources & links

ClinicalTrials.gov NCT07186842

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